Sawitzki B, Harden PN, Reinke P, et al. - In kidney transplant trials, multiple regulatory cell-based medicinal products (CBMPs) were assessed, to ascertain whether regulatory CBMPs afford a safe option when integrated with reduced immunosuppressive treatment. The ONE Study included 7 investigator-led, single-arm trials performed internationally at 8 hospitals in France, Germany, Italy, the UK, and the USA (60 week follow-up). Participants were living-donor kidney transplant recipients aged 18 years and older. A standard-of-care group administered basiliximab, tapered steroids, mycophenolate mofetil, and tacrolimus was the reference group trial (RGT). This study included 104 participants who received the treatment. In the recipients in the RGT, standard-of-care immunosuppression led to a 12% biopsy-confirmed acute rejection (BCAR) rate (expected range 3·2–18·0). For the six parallel CTG (cell therapy group) trials, the overall BCAR rate was estimated to be 16%. Overall, findings revealed the safety of regulatory cell therapy in living-donor kidney transplant recipients, as well as showed that regulatory cell therapy is achievable in these patients. This therapy was shown to be related to fewer infectious complications, but similar rejection rates in the first year. Thus, experts suggested the potential usefulness of immune cell therapy as a treatment approach to minimise the burden of general immunosuppression in recipients of kidney transplant.